A Study to Investigate Tolerability and Efficacy of Asciminib (Oral) Versus Nilotinib (Oral) in Adult Participants (≥18 Years of Age) With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP)
Summary
The primary purpose of this study was to assess the tolerability of oral asciminib (80 mg QD) in comparison with that of the second generation (2G) Tyrosine Kinase Inhibitor (TKI) nilotinib (300 mg BID), in adult patients with newly diagnosed Positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP).
Timeline
- Start
- 2022-11-21
- Primary completion
- 2025-05-15
- Completion
- 2031-07-07
Outcome
Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)
registry analysis (superiority test); Asciminib vs Nilotinib; p = 0.004; Hazard Ratio (HR) 0.45 (95% CI 0.25 to 0.81) NCT05456191 ↗
registry The study met its primary objective based on the formal interim analysis. NCT05456191 ↗
registry analysis (superiority test); Asciminib vs Nilotinib; p = 0.001; Hazard Ratio (HR) 0.46 (95% CI 0.27 to 0.76) NCT05456191 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Asciminib | Unknown | 80 mg | Oral |
| Comparator | Nilotinib | Small molecule | 300 mg | Oral |